Drugplain

Unisom PM Pain Nighttime Sleep Aid and Pain Reliever 325 mg/1

Acetaminophen and Diphenhydramine Hydrochloride · TABLET, FILM COATED · Chattem, Inc.

No Recall HistoryCurrently in Shortage
Plain English

Unisom PM Pain Nighttime Sleep Aid and Pain Reliever is a tablet, film coated containing acetaminophen and diphenhydramine hydrochloride at 325 mg/1, taken oral. Manufactured by Chattem, Inc..

Key Facts

Brand Name
Unisom PM Pain Nighttime Sleep Aid and Pain Reliever
Generic Name
Acetaminophen and Diphenhydramine Hydrochloride
NDC Code (Product)
41167-0040
Manufacturer
Chattem, Inc.
Strength
325 mg/1
Dosage Form
TABLET, FILM COATED
Route
ORAL
Marketing Status
Application #
M013
Marketing Start
12/01/2009

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

completed suicide158 reports
toxicity to various agents127 reports
death34 reports
cardio-respiratory arrest28 reports
fatigue26 reports
intentional product misuse25 reports
pain25 reports
drug ineffective24 reports
joint swelling20 reports
somnolence20 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses for the temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness

Dosage & Administration

Directions • do not take more than directed (see overdose warning ) adults and children 12 years and older: • take 1 caplet at bedtime • do not take more than 1 caplet of this product in 24 hours children under 12 years: do not use this adult product in children under 12 years of age, this will provide more than the recommended dose (overdose) and may cause liver damage

Warnings

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 4,000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. in children under 12 years of age with any other product containing diphenhydramine, even one used on skin if you have ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if you have liver disease a breathing problem such as emphysema or chronic bronchitis trouble urinating due to an enlarged prostate gland glaucoma Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers When using this product drowsiness will occur avoid alcoholic drinks do not drive a motor vehicle or operate machinery Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious medical illness. pain gets worse or la

Frequently Asked Questions

What is Unisom PM Pain Nighttime Sleep Aid and Pain Reliever used for?

Unisom PM Pain Nighttime Sleep Aid and Pain Reliever contains Acetaminophen and Diphenhydramine Hydrochloride. It is a tablet, film coated taken oral. Consult your doctor for specific uses.

Is Unisom PM Pain Nighttime Sleep Aid and Pain Reliever a controlled substance?

Unisom PM Pain Nighttime Sleep Aid and Pain Reliever is not classified as a controlled substance by the DEA.

What is the generic name for Unisom PM Pain Nighttime Sleep Aid and Pain Reliever?

The generic name for Unisom PM Pain Nighttime Sleep Aid and Pain Reliever is Acetaminophen and Diphenhydramine Hydrochloride. There are 11 other brand versions of Acetaminophen and Diphenhydramine Hydrochloride.

What is the NDC code for Unisom PM Pain Nighttime Sleep Aid and Pain Reliever 325 mg/1?

The NDC (National Drug Code) for Unisom PM Pain Nighttime Sleep Aid and Pain Reliever 325 mg/1 is 41167-0040, listed by Chattem, Inc..